Regulatory Specialist
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Job Type | Permanent |
Location | Alcester |
Area | Warwickshire, England |
Sector | Manufacturing - Quality |
Salary | £28000 - £35000 per annum |
Currency | GBP |
Start Date | ASAP |
Advertiser | Rhys Aitchison |
Job Ref | ER13076RA |
- Description
- Regulatory Specialist
Playing a vital role in ensuring the successful launch of a life-changing medical product which will lengthen and improve millions of lives around the world, you will work with a small team of dedicated engineers to ensure all checks and documentation are in place to comply with regulatory processes.
With their products going into production this month and multiple international markets already highlighted, you will support the Regulatory Manager in the application for the FDA 510(k) process as well as ensuring compliance with other markets and the appropriate quality management systems.
You will work closely with senior engineers and managers and as such will receive extensive on the job training, allowing you to grow and progress your skills within the area.
For this role you will need a minimum of two years’ experience working in a regulatory environment for medical devices, ideally combined with experience of the various pathways for FDA submission. Experience on the commercial side, dealing with technical files and CE marking is also beneficial.
If it sounds like this could be the role for you and you are ready to get stuck into to an interesting product range that is going to make an impact, then click apply now!